Phase 3
Completed N=303
Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00723190 ↗Enrolled (actual)
303
Serious AEs
0.7%
Results posted
Feb 2012
Primary outcomePrimary: Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) — 301; 246; 178; 2 Participants
Summary
The purpose of this 12-month, multi-center, open-label study is to evaluate the safety of CLONICEL (clonidine HCl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (ADHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs]) |
954; 438; 2 | — |
| PRIMARY Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett's (QTcB) at Week 4 |
17.9; 1.4; -8.0 | — |
| PRIMARY Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12 |
0.3; 0.4; 0.6; 0.7; 0.9; 1.2 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Week 4 |
-4.2 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Week 4 |
-5.0 | — |
| PRIMARY Change From Baseline in Body Temperature at Week 4 |
-0.08 | — |
| PRIMARY Change From Baseline in Heart Rate at Week 4 |
-7.0 | — |
| PRIMARY Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4 |
-10.6 | — |
| SECONDARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12 |
-13.7; -14.4; -14.8; -16.3; -14.6; -18.1 | — |
| SECONDARY Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12 |
-1.2; -1.3; -1.3; -1.5; -1.4; -1.7 | — |
| SECONDARY Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12 |
2.5; 2.5; 2.5; 2.3; 2.4; 2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subject who has completed either study CLON-301 or study CLON-302, or discontinued early for reasons other than adverse events necessitating discontinuation
- Age between 6 and 17 years, inclusive
- Diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria
- General good health as judged by the Principal Investigator
- Body mass index (BMI) ≥ 5th percentile of the subject's age group according to the CDC growth chart. BMI is calculated using the formula: weight (kg) / [height (m)]2
- Subject as well as parent/guardian able to sign informed assent or consent form
Exclusion Criteria
- If female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device
- Presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study.
- Presence of clinically significant abnormality on centrally interpreted electrocardiogram readings
- History or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis I or axis II disorder that could interfere with study assessments in the judgment of the Principal Investigator
- Presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine
- Presence of alcohol or drug abuse.
Data sourced from ClinicalTrials.gov (NCT00723190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.